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TDMS Study 88031-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 02/04/02       
EXPERIMENT: 88031 TEST: 05                                                                                     TIME: 10:28:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: MISSING                                                                                           CAS: 25265-71-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              FINAL#3                                                               
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 02/04/02       
EXPERIMENT: 88031 TEST: 05                                                                                     TIME: 10:28:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: MISSING                                                                                           CAS: 25265-71-8      
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Prostate                                                                           
                                                 Salivary Glands                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 02/04/02       
EXPERIMENT: 88031 TEST: 05                                                                                     TIME: 10:28:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: MISSING                                                                                           CAS: 25265-71-8      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                DIPROPYLENE GLYCOL                                                                                
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma Malignant                                                                   
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Clitoral/Preputial Gland               Carcinoma or Adenoma                                                                         
Islets, Pancreatic                     Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Skin                                   Fibroma                                                                                      
                                       Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
Testes                                 Adenoma                                                                                      
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Clitoral/Preputial Gland               Carcinoma or Adenoma                                                                         
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
All Organs                             Hemangiosarcoma                                                                              
                                       Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                 DIPROPYLENE GLYCOL        
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    2/49 (4%)    0/50 (0%)    0/48 (0%)   |1/49 (2%)    0/47 (0%)    1/47 (2%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     0/37.58      2/42.09      0/42.10      0/24.30     |1/42.75      0/41.25      1/44.49      0/42.03      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         0.0%         0.0%        |2.3%         0.0%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    1/27 (4%)    0/27 (0%)    0/0 (0%)    |1/30 (3%)    0/31 (0%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          698          ---          ---         |729 (T)      ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.971N     P=0.287      (e)          (e)         |P=0.480N     P=0.493N     P=0.708N     P=0.493N     | 
|POLY 3             |     P=0.420N     P=0.263      (e)          (e)         |P=0.481N     P=0.507N     P=0.752N     P=0.503N     | 
|POLY 1.5           |     P=0.411N     P=0.257      (e)          (e)         |P=0.481N     P=0.507N     P=0.758N     P=0.504N     | 
|POLY 6             |     P=0.392N     P=0.271      (e)          (e)         |P=0.482N     P=0.508N     P=0.745N     P=0.504N     | 
|LOGISTIC REGRESSION|     P=0.737N     P=0.270      (e)          (e)         |P=0.480N     (e)          P=0.708N     (e)          | 
|COCH-ARM / FISHERS |     P=0.390N     P=0.258      (e)          (e)         |P=0.483N     P=0.510N     P=0.742      P=0.510N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/47 (9%)    7/49 (14%)   12/50 (24%)  1/47 (2%)   |0/49 (0%)    3/47 (6%)    1/46 (2%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     4/37.88      7/42.10      12/43.89     1/24.31     |0/42.75      3/41.63      1/43.84      0/42.03      | 
|POLY-3 PERCENT (g) |     10.6%        16.6%        27.3%        4.1%        |0.0%         7.2%         2.3%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    4/27 (15%)   8/27 (30%)   0/0 (0%)    |0/30 (0%)    2/31 (7%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     697          711          340          614         |---          622          725          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.146      P=0.388      P=0.063      P=0.335     |P=0.265N     P=0.127      P=0.546      (e)          | 
|POLY 3             |     P=0.308N     P=0.323      P=0.049 *    P=0.339N    |P=0.263N     P=0.113      P=0.505      (e)          | 
|POLY 1.5           |     P=0.140N     P=0.310      P=0.045 *    P=0.250N    |P=0.263N     P=0.113      P=0.499      (e)          | 
|POLY 6             |     P=0.424      P=0.339      P=0.051      P=0.512N    |P=0.265N     P=0.114      P=0.512      (e)          | 
|LOGISTIC REGRESSION|     P=0.296N     P=0.367      P=0.042 *    P=0.700N    |P=0.267N     P=0.114      P=0.521      (e)          | 
|COCH-ARM / FISHERS |     P=0.050N     P=0.287      P=0.036 *    P=0.181N    |P=0.268N     P=0.113      P=0.484      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/47 (11%)   0/49 (0%)    2/50 (4%)    0/47 (0%)   |2/49 (4%)    0/47 (0%)    0/46 (0%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     5/38.29      0/41.97      2/43.00      0/23.91     |2/42.86      0/41.25      0/43.82      0/42.03      | 
|POLY-3 PERCENT (g) |     13.1%        0.0%         4.7%         0.0%        |4.7%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/23 (13%)   0/27 (0%)    1/27 (4%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     511          ---          340          ---         |702          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.307N     P=0.024N*    P=0.172N     P=0.537N    |P=0.311N     P=0.237N     P=0.201N     P=0.240N     | 
|POLY 3             |     P=0.161N     P=0.023N*    P=0.170N     P=0.094N    |P=0.316N     P=0.245N     P=0.232N     P=0.241N     | 
|POLY 1.5           |     P=0.125N     P=0.024N*    P=0.175N     P=0.054N    |P=0.315N     P=0.245N     P=0.239N     P=0.242N     | 
|POLY 6             |     P=0.199N     P=0.021N*    P=0.167N     P=0.213N    |P=0.318N     P=0.247N     P=0.225N     P=0.242N     | 
|LOGISTIC REGRESSION|     P=0.058N     P=0.027N*    P=0.218N     P=0.106N    |P=0.309N     P=0.246N     P=0.230N     P=0.241N     | 
|COCH-ARM / FISHERS |     P=0.087N     P=0.025N*    P=0.193N     P=0.028N*   |P=0.312N     P=0.258N     P=0.263N     P=0.258N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/47 (19%)   7/49 (14%)   13/50 (26%)  1/47 (2%)   |2/49 (4%)    3/47 (6%)    1/46 (2%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     9/38.58      7/42.10      13/43.89     1/24.31     |2/42.86      3/41.63      1/43.84      0/42.03      | 
|POLY-3 PERCENT (g) |     23.3%        16.6%        29.6%        4.1%        |4.7%         7.2%         2.3%         0.0%         | 
|TERMINAL (d)       |     4/23 (17%)   4/27 (15%)   9/27 (33%)   0/0 (0%)    |0/30 (0%)    2/31 (7%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     511          711          340          614         |702          622          725          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.387      P=0.264N     P=0.374      P=0.648     |P=0.117N     P=0.508      P=0.432N     P=0.240N     | 
|POLY 3             |     P=0.121N     P=0.317N     P=0.346      P=0.050N    |P=0.118N     P=0.487      P=0.492N     P=0.241N     | 
|POLY 1.5           |     P=0.039N*    P=0.330N     P=0.330      P=0.020N*   |P=0.117N     P=0.486      P=0.503N     P=0.242N     | 
|POLY 6             |     P=0.408N     P=0.302N     P=0.353      P=0.178N    |P=0.120N     P=0.487      P=0.480N     P=0.242N     | 
|LOGISTIC REGRESSION|     P=0.092N     P=0.285N     P=0.313      P=0.129N    |P=0.116N     P=0.483      P=0.483N     P=0.241N     | 
|COCH-ARM / FISHERS |     P=0.009N**   P=0.358N     P=0.288      P=0.008N**  |P=0.118N     P=0.480      P=0.524N     P=0.258N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/47 (2%)    3/50 (6%)    1/50 (2%)   |6/48 (13%)   9/44 (20%)   4/48 (8%)    4/48 (8%)    | 
|POLY-3 RATE (b)    |     3/40.37      1/41.26      3/42.10      1/25.88     |6/41.42      9/38.95      4/44.12      4/42.17      | 
|POLY-3 PERCENT (g) |     7.4%         2.4%         7.1%         3.9%        |14.5%        23.1%        9.1%         9.5%         | 
|TERMINAL (d)       |     1/23 (4%)    0/27 (0%)    3/27 (11%)   0/0 (0%)    |6/29 (21%)   8/30 (27%)   4/37 (11%)   3/30 (10%)   | 
|FIRST INCIDENCE    |     654          586          729 (T)      484         |729 (T)      585          729 (T)      725          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.389      P=0.266N     P=0.609N     P=0.579     |P=0.182N     P=0.307      P=0.224N     P=0.346N     | 
|POLY 3             |     P=0.543N     P=0.297N     P=0.644N     P=0.475N    |P=0.164N     P=0.240      P=0.330N     P=0.357N     | 
|POLY 1.5           |     P=0.447N     P=0.308N     P=0.648N     P=0.386N    |P=0.162N     P=0.237      P=0.345N     P=0.358N     | 
|POLY 6             |     P=0.505      P=0.281N     P=0.642N     P=0.624N    |P=0.170N     P=0.244      P=0.313N     P=0.362N     | 
|LOGISTIC REGRESSION|     P=0.405N     P=0.338N     P=0.631N     P=0.360N    |P=0.173N     P=0.233      P=0.224N     P=0.358N     | 
|COCH-ARM / FISHERS |     P=0.336N     P=0.332N     P=0.661N     P=0.309N    |P=0.167N     P=0.227      P=0.370N     P=0.370N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    1/47 (2%)    2/50 (4%)    0/50 (0%)   |5/48 (10%)   5/44 (11%)   2/48 (4%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     3/41.08      1/41.53      2/42.51      0/25.17     |5/41.79      5/38.49      2/44.12      1/42.74      | 
|POLY-3 PERCENT (g) |     7.3%         2.4%         4.7%         0.0%        |12.0%        13.0%        4.5%         2.3%         | 
|TERMINAL (d)       |     1/23 (4%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |4/29 (14%)   4/30 (13%)   2/37 (5%)    0/30 (0%)    | 
|FIRST INCIDENCE    |     511          456          627          ---         |626          725          729 (T)      542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.312N     P=0.293N     P=0.456N     P=0.305N    |P=0.065N     P=0.613N     P=0.139N     P=0.100N     | 
|POLY 3             |     P=0.258N     P=0.301N     P=0.484N     P=0.230N    |P=0.059N     P=0.578      P=0.194N     P=0.095N     | 
|POLY 1.5           |     P=0.199N     P=0.310N     P=0.488N     P=0.167N    |P=0.059N     P=0.579      P=0.202N     P=0.096N     | 
|POLY 6             |     P=0.337N     P=0.287N     P=0.480N     P=0.361N    |P=0.060N     P=0.576      P=0.186N     P=0.096N     | 
|LOGISTIC REGRESSION|     P=0.070N     P=0.452N     P=0.547N     P=0.085N    |P=0.060N     P=0.586      P=0.187N     P=0.105N     | 
|COCH-ARM / FISHERS |     P=0.137N     P=0.332N     P=0.500N     P=0.121N    |P=0.061N     P=0.573      P=0.218N     P=0.102N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   2/47 (4%)    5/50 (10%)   1/50 (2%)   |10/48 (21%)  14/44 (32%)  6/48 (13%)   5/48 (10%)   | 
|POLY-3 RATE (b)    |     6/41.55      2/42.01      5/42.51      1/25.88     |10/41.79     14/38.97     6/44.12      5/42.76      | 
|POLY-3 PERCENT (g) |     14.4%        4.8%         11.8%        3.9%        |23.9%        35.9%        13.6%        11.7%        | 
|TERMINAL (d)       |     2/23 (9%)    0/27 (0%)    3/27 (11%)   0/0 (0%)    |9/29 (31%)   12/30 (40%)  6/37 (16%)   3/30 (10%)   | 
|FIRST INCIDENCE    |     511          456          627          484         |626          585          729 (T)      542          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.581N     P=0.118N     P=0.429N     P=0.509N    |P=0.037N*    P=0.261      P=0.086N     P=0.117N     | 
|POLY 3             |     P=0.284N     P=0.128N     P=0.484N     P=0.175N    |P=0.027N*    P=0.172      P=0.170N     P=0.116N     | 
|POLY 1.5           |     P=0.181N     P=0.137N     P=0.486N     P=0.102N    |P=0.027N*    P=0.173      P=0.183N     P=0.118N     | 
|POLY 6             |     P=0.457N     P=0.116N     P=0.485N     P=0.357N    |P=0.028N*    P=0.171      P=0.157N     P=0.117N     | 
|LOGISTIC REGRESSION|     P=0.051N     P=0.214N     P=0.497N     P=0.044N*   |P=0.032N*    P=0.171      P=0.141N     P=0.123N     | 
|COCH-ARM / FISHERS |     P=0.094N     P=0.155N     P=0.500N     P=0.056N    |P=0.033N*    P=0.168      P=0.206N     P=0.130N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Benign                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    1/50 (2%)    0/49 (0%)   |0/50 (0%)    2/50 (4%)    4/50 (8%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/40.56      3/42.41      1/42.17      0/24.59     |0/43.16      2/43.38      4/45.88      1/43.66      | 
|POLY-3 PERCENT (g) |     4.9%         7.1%         2.4%         0.0%        |0.0%         4.6%         8.7%         2.3%         | 
|TERMINAL (d)       |     0/23 (0%)    3/27 (11%)   0/27 (0%)    0/0 (0%)    |0/30 (0%)    1/31 (3%)    4/38 (11%)   1/31 (3%)    | 
|FIRST INCIDENCE    |     565          729 (T)      712          ---         |---          634          729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.495N     P=0.556      P=0.459N     P=0.576N    |P=0.584N     P=0.243      P=0.096      P=0.507      | 
|POLY 3             |     P=0.198N     P=0.520      P=0.486N     P=0.361N    |P=0.573N     P=0.238      P=0.068      P=0.502      | 
|POLY 1.5           |     P=0.160N     P=0.514      P=0.490N     P=0.298N    |P=0.571N     P=0.238      P=0.065      P=0.503      | 
|POLY 6             |     P=0.233N     P=0.531      P=0.484N     P=0.474N    |P=0.579N     P=0.238      P=0.072      P=0.500      | 
|LOGISTIC REGRESSION|     P=0.210N     P=0.518      P=0.511N     P=0.241N    |P=0.581N     P=0.237      P=0.096      P=0.507      | 
|COCH-ARM / FISHERS |     P=0.118N     P=0.500      P=0.500N     P=0.253N    |P=0.578N     P=0.247      P=0.059      P=0.500      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/44 (5%)    3/48 (6%)    0/50 (0%)    0/47 (0%)   |0/47 (0%)    1/48 (2%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/36.11      3/41.84      0/42.10      0/23.65     |0/41.03      1/41.49      0/45.05      0/42.76      | 
|POLY-3 PERCENT (g) |     5.5%         7.2%         0.0%         0.0%        |0.0%         2.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    2/27 (7%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      649          ---          ---         |---          717          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.488N     P=0.566      P=0.203N     P=1.000     |P=0.616N     P=0.518      (e)          (e)          | 
|POLY 3             |     P=0.145N     P=0.567      P=0.203N     P=0.342N    |P=0.612N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.130N     P=0.558      P=0.204N     P=0.277N    |P=0.609N     P=0.504      (e)          (e)          | 
|POLY 6             |     P=0.136N     P=0.579      P=0.204N     P=0.460N    |P=0.616N     P=0.501      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.274N     P=0.573      (e)          (e)         |P=0.606N     P=0.500      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.106N     P=0.542      P=0.216N     P=0.231N    |P=0.607N     P=0.505      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/44 (0%)    4/48 (8%)    0/50 (0%)    2/47 (4%)   |0/47 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/36.11      4/41.62      0/42.10      2/24.37     |0/41.03      0/41.44      0/45.05      0/42.76      | 
|POLY-3 PERCENT (g) |     0.0%         9.6%         0.0%         8.2%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    3/27 (11%)   0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          709          ---          564         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.011 *    P=0.092      (e)          P=0.032 *   |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.409      P=0.079      (e)          P=0.163     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.469      P=0.077      (e)          P=0.203     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.350      P=0.082      (e)          P=0.114     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.252      P=0.090      (e)          P=0.210     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.546      P=0.070      (e)          P=0.264     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/44 (5%)    7/48 (15%)   0/50 (0%)    2/47 (4%)   |0/47 (0%)    1/48 (2%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/36.11      7/41.92      0/42.10      2/24.37     |0/41.03      1/41.49      0/45.05      0/42.76      | 
|POLY-3 PERCENT (g) |     5.5%         16.7%        0.0%         8.2%        |0.0%         2.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    5/27 (19%)   0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      649          ---          564         |---          717          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.111      P=0.127      P=0.203N     P=0.032 *   |P=0.616N     P=0.518      (e)          (e)          | 
|POLY 3             |     P=0.379N     P=0.117      P=0.203N     P=0.545     |P=0.612N     P=0.502      (e)          (e)          | 
|POLY 1.5           |     P=0.327N     P=0.112      P=0.204N     P=0.635     |P=0.609N     P=0.504      (e)          (e)          | 
|POLY 6             |     P=0.395N     P=0.125      P=0.204N     P=0.394     |P=0.616N     P=0.501      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.614      P=0.125      (e)          P=0.363     |P=0.606N     P=0.500      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.259N     P=0.101      P=0.216N     P=0.666N    |P=0.607N     P=0.505      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Lipoma                                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/50 (0%)    2/50 (4%)    0/48 (0%)   |0/49 (0%)    0/49 (0%)    0/49 (0%)    0/47 (0%)    | 
|POLY-3 RATE (b)    |     0/37.91      0/42.41      2/42.31      0/24.20     |0/42.42      0/42.07      0/45.12      0/42.03      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.7%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    1/27 (4%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          674          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.710      (e)          P=0.264      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.630      (e)          P=0.262      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.730N     (e)          P=0.259      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.354      (e)          P=0.264      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.793      (e)          P=0.261      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.655N     (e)          P=0.263      (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/49 (6%)    0/50 (0%)    1/49 (2%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     2/40.21      3/42.45      0/42.10      1/25.37     |0/43.16      2/43.04      0/45.88      0/43.15      | 
|POLY-3 PERCENT (g) |     5.0%         7.1%         0.0%         3.9%        |0.0%         4.7%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    2/27 (7%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    2/31 (7%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     645          586          ---          438         |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.661      P=0.555      P=0.225N     P=0.589     |P=0.390N     P=0.245      (e)          (e)          | 
|POLY 3             |     P=0.422N     P=0.525      P=0.227N     P=0.652N    |P=0.396N     P=0.236      (e)          (e)          | 
|POLY 1.5           |     P=0.393N     P=0.512      P=0.230N     P=0.581N    |P=0.394N     P=0.237      (e)          (e)          | 
|POLY 6             |     P=0.408N     P=0.543      P=0.224N     P=0.659     |P=0.400N     P=0.235      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.299N     P=0.503      P=0.230N     P=0.469N    |(e)          P=0.245      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.341N     P=0.490      P=0.247N     P=0.508N    |P=0.394N     P=0.247      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/49 (4%)    2/50 (4%)    1/49 (2%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     1/39.90      2/42.06      2/42.59      1/24.98     |1/43.16      1/43.04      1/45.88      0/43.15      | 
|POLY-3 PERCENT (g) |     2.5%         4.8%         4.7%         4.0%        |2.3%         2.3%         2.2%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    0/27 (0%)    1/27 (4%)    0/0 (0%)    |1/30 (3%)    1/31 (3%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      711          583          617         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.251      P=0.577      P=0.553      P=0.310     |P=0.331N     P=0.755N     P=0.708N     P=0.493N     | 
|POLY 3             |     P=0.582      P=0.518      P=0.523      P=0.647     |P=0.336N     P=0.760      P=0.747N     P=0.500N     | 
|POLY 1.5           |     P=0.608N     P=0.509      P=0.515      P=0.705     |P=0.335N     P=0.760N     P=0.752N     P=0.500N     | 
|POLY 6             |     P=0.424      P=0.533      P=0.532      P=0.542     |P=0.338N     P=0.759      P=0.741N     P=0.501N     | 
|LOGISTIC REGRESSION|     P=0.647      P=0.560      P=0.507      P=0.596     |P=0.331N     P=0.755N     P=0.708N     (e)          | 
|COCH-ARM / FISHERS |     P=0.518N     P=0.492      P=0.500      P=0.747     |P=0.337N     P=0.753N     P=0.753N     P=0.505N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    5/49 (10%)   2/50 (4%)    2/49 (4%)   |1/50 (2%)    3/50 (6%)    1/50 (2%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     3/40.21      5/42.54      2/42.59      2/25.76     |1/43.16      3/43.04      1/45.88      0/43.15      | 
|POLY-3 PERCENT (g) |     7.5%         11.8%        4.7%         7.8%        |2.3%         7.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    2/27 (7%)    1/27 (4%)    0/0 (0%)    |1/30 (3%)    3/31 (10%)   1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     645          586          583          438         |729 (T)      729 (T)      729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.277      P=0.448      P=0.446N     P=0.219     |P=0.169N     P=0.316      P=0.708N     P=0.493N     | 
|POLY 3             |     P=0.474N     P=0.387      P=0.474N     P=0.660     |P=0.175N     P=0.304      P=0.747N     P=0.500N     | 
|POLY 1.5           |     P=0.392N     P=0.371      P=0.482N     P=0.602N    |P=0.175N     P=0.306      P=0.752N     P=0.500N     | 
|POLY 6             |     P=0.554N     P=0.411      P=0.465N     P=0.499     |P=0.178N     P=0.302      P=0.741N     P=0.501N     | 
|LOGISTIC REGRESSION|     P=0.356N     P=0.381      P=0.488N     P=0.590N    |P=0.169N     P=0.316      P=0.708N     (e)          | 
|COCH-ARM / FISHERS |     P=0.293N     P=0.346      P=0.500N     P=0.510N    |P=0.177N     P=0.309      P=0.753N     P=0.505N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |4/50 (8%)    4/50 (8%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/39.90      0/42.41      0/42.10      0/25.17     |4/43.75      4/43.04      2/45.88      2/43.85      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |9.1%         9.3%         4.4%         4.6%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |3/30 (10%)   4/31 (13%)   2/38 (5%)    1/31 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |542          729 (T)      729 (T)      681          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.272N     P=0.627N     P=0.248N     P=0.330N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.273N     P=0.635      P=0.315N     P=0.336N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.271N     P=0.640      P=0.323N     P=0.333N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.279N     P=0.628      P=0.306N     P=0.342N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.269N     P=0.643      P=0.329N     P=0.335N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.272N     P=0.643N     P=0.339N     P=0.339N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    7/50 (14%)   1/50 (2%)    0/50 (0%)   |36/50 (72%)  35/50 (70%)  30/50 (60%)  22/50 (44%)  | 
|POLY-3 RATE (b)    |     1/39.90      7/42.41      1/42.69      0/25.17     |36/46.35     35/44.40     30/46.63     22/44.99     | 
|POLY-3 PERCENT (g) |     2.5%         16.5%        2.3%         0.0%        |77.7%        78.8%        64.3%        48.9%        | 
|TERMINAL (d)       |     1/23 (4%)    7/27 (26%)   0/27 (0%)    0/0 (0%)    |25/30 (83%)  27/31 (87%)  26/38 (68%)  14/31 (45%)  | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      543          ---         |247          585          597          626          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.413N     P=0.047 *    P=0.735N     P=1.000     |P=0.003N**   P=0.444N     P=0.013N*    P=0.010N*    | 
|POLY 3             |     P=0.106N     P=0.036 *    P=0.746N     P=0.588N    |P<0.001N**   P=0.551      P=0.107N     P=0.002N**   | 
|POLY 1.5           |     P=0.076N     P=0.034 *    P=0.751N     P=0.544N    |P<0.001N**   P=0.593N     P=0.122N     P=0.002N**   | 
|POLY 6             |     P=0.143N     P=0.039 *    P=0.740N     P=0.654N    |P<0.001N**   P=0.476      P=0.096N     P=0.003N**   | 
|LOGISTIC REGRESSION|     P=0.206N     P=0.047 *    P=0.746      (e)         |P<0.001N**   P=0.512N     P=0.073N     P=0.003N**   | 
|COCH-ARM / FISHERS |     P=0.053N     P=0.030 *    P=0.753N     P=0.500N    |P<0.001N**   P=0.500N     P=0.146N     P=0.004N**   | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    7/50 (14%)   1/50 (2%)    0/50 (0%)   |37/50 (74%)  37/50 (74%)  30/50 (60%)  23/50 (46%)  | 
|POLY-3 RATE (b)    |     1/39.90      7/42.41      1/42.69      0/25.17     |37/46.94     37/44.40     30/46.63     23/44.99     | 
|POLY-3 PERCENT (g) |     2.5%         16.5%        2.3%         0.0%        |78.8%        83.3%        64.3%        51.1%        | 
|TERMINAL (d)       |     1/23 (4%)    7/27 (26%)   0/27 (0%)    0/0 (0%)    |25/30 (83%)  29/31 (94%)  26/38 (68%)  15/31 (48%)  | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      543          ---         |247          585          597          626          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.413N     P=0.047 *    P=0.735N     P=1.000N    |P=0.003N**   P=0.518N     P=0.008N**   P=0.010N*    | 
|POLY 3             |     P=0.106N     P=0.036 *    P=0.746N     P=0.588N    |P<0.001N**   P=0.379      P=0.083N     P=0.003N**   | 
|POLY 1.5           |     P=0.076N     P=0.034 *    P=0.751N     P=0.544N    |P<0.001N**   P=0.473      P=0.090N     P=0.003N**   | 
|POLY 6             |     P=0.143N     P=0.039 *    P=0.740N     P=0.654N    |P<0.001N**   P=0.261      P=0.081N     P=0.004N**   | 
|LOGISTIC REGRESSION|     P=0.206N     P=0.047 *    P=0.746      (e)         |P<0.001N**   P=0.591      P=0.054N     P=0.002N**   | 
|COCH-ARM / FISHERS |     P=0.053N     P=0.030 *    P=0.753N     P=0.500N    |P<0.001N**   P=0.590N     P=0.101N     P=0.004N**   | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/39.90      0/42.41      0/42.10      0/25.17     |0/43.16      0/43.04      1/46.21      2/44.41      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.2%         4.5%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          638          533          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.098      (e)          P=0.519      P=0.238      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.102      (e)          P=0.514      P=0.243      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.101      (e)          P=0.508      P=0.242      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.102      (e)          P=0.520      P=0.243      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.071      (e)          P=0.475      P=0.180      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.097      (e)          P=0.500      P=0.247      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Mixed Tumor Benign                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/44 (5%)    0/49 (0%)    0/50 (0%)    0/47 (0%)   |0/47 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/36.72      0/41.98      0/42.10      0/23.65     |0/41.03      0/41.44      0/45.05      0/42.76      | 
|POLY-3 PERCENT (g) |     5.5%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     584          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.504N     P=0.214N     P=0.216N     P=0.578N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.309N     P=0.207N     P=0.207N     P=0.346N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.319N     P=0.208N     P=0.206N     P=0.280N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.238N     P=0.207N     P=0.210N     P=0.466N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.268N     P=0.228N     P=0.222N     P=0.236N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.305N     P=0.221N     P=0.216N     P=0.231N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/45 (2%)    2/48 (4%)    0/49 (0%)    0/50 (0%)   |0/49 (0%)    0/47 (0%)    0/47 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     1/36.39      2/40.78      0/41.10      0/25.17     |0/42.42      0/40.75      0/43.81      0/43.15      | 
|POLY-3 PERCENT (g) |     2.8%         4.9%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/22 (5%)    1/26 (4%)    0/26 (0%)    0/0 (0%)    |0/30 (0%)    0/30 (0%)    0/36 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      649          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.728N     P=0.548      P=0.467N     P=1.000N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.270N     P=0.540      P=0.476N     P=0.571N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.255N     P=0.533      P=0.478N     P=0.525N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.249N     P=0.551      P=0.474N     P=0.641N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.401N     P=0.540      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.226N     P=0.524      P=0.479N     P=0.474N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/47 (32%)  21/49 (43%)  18/50 (36%)  7/49 (14%)  |20/48 (42%)  18/45 (40%)  20/50 (40%)  13/47 (28%)  | 
|POLY-3 RATE (b)    |     15/40.01     21/44.40     18/45.08     7/27.83     |20/43.11     18/41.74     20/46.97     13/43.05     | 
|POLY-3 PERCENT (g) |     37.5%        47.3%        39.9%        25.2%       |46.4%        43.1%        42.6%        30.2%        | 
|TERMINAL (d)       |     9/23 (39%)   12/27 (44%)  9/27 (33%)   0/0 (0%)    |15/30 (50%)  10/31 (32%)  16/38 (42%)  9/31 (29%)   | 
|FIRST INCIDENCE    |     582          417          562          431         |413          542          598          577          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.011 *    P=0.342      P=0.504      P=0.002 **  |P=0.099N     P=0.402N     P=0.273N     P=0.100N     | 
|POLY 3             |     P=0.100N     P=0.242      P=0.497      P=0.209N    |P=0.068N     P=0.466N     P=0.439N     P=0.089N     | 
|POLY 1.5           |     P=0.024N*    P=0.221      P=0.468      P=0.091N    |P=0.068N     P=0.487N     P=0.470N     P=0.094N     | 
|POLY 6             |     P=0.367N     P=0.272      P=0.532      P=0.535N    |P=0.072N     P=0.430N     P=0.401N     P=0.084N     | 
|LOGISTIC REGRESSION|     P=0.058N     P=0.214      P=0.441      P=0.451N    |P=0.067N     P=0.509N     P=0.443N     P=0.094N     | 
|COCH-ARM / FISHERS |     P=0.003N**   P=0.185      P=0.417      P=0.034N*   |P=0.076N     P=0.519N     P=0.515N     P=0.111N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/47 (32%)  21/49 (43%)  19/50 (38%)  7/49 (14%)  |21/48 (44%)  18/45 (40%)  21/50 (42%)  13/47 (28%)  | 
|POLY-3 RATE (b)    |     15/40.01     21/44.40     19/45.67     7/27.83     |21/43.69     18/41.74     21/47.42     13/43.05     | 
|POLY-3 PERCENT (g) |     37.5%        47.3%        41.6%        25.2%       |48.1%        43.1%        44.3%        30.2%        | 
|TERMINAL (d)       |     9/23 (39%)   12/27 (44%)  9/27 (33%)   0/0 (0%)    |15/30 (50%)  10/31 (32%)  16/38 (42%)  9/31 (29%)   | 
|FIRST INCIDENCE    |     582          417          543          431         |413          542          597          577          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.014 *    P=0.342      P=0.431      P=0.002 **  |P=0.079N     P=0.332N     P=0.273N     P=0.072N     | 
|POLY 3             |     P=0.104N     P=0.242      P=0.433      P=0.209N    |P=0.054N     P=0.404N     P=0.440N     P=0.065N     | 
|POLY 1.5           |     P=0.025N*    P=0.221      P=0.397      P=0.091N    |P=0.053N     P=0.417N     P=0.469N     P=0.067N     | 
|POLY 6             |     P=0.384N     P=0.272      P=0.477      P=0.535N    |P=0.060N     P=0.378N     P=0.402N     P=0.064N     | 
|LOGISTIC REGRESSION|     P=0.043N*    P=0.214      P=0.356      P=0.451N    |P=0.052N     P=0.430N     P=0.471N     P=0.067N     | 
|COCH-ARM / FISHERS |     P=0.003N**   P=0.185      P=0.340      P=0.034N*   |P=0.057N     P=0.438N     P=0.512N     P=0.077N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |                                                    | 
|POLY-3 RATE (b)    |     1/38.81      1/42.41      2/42.10      0/25.17     |                                                    | 
|POLY-3 PERCENT (g) |     2.6%         2.4%         4.8%         0.0%        |                                                    | 
|TERMINAL (d)       |     0/23 (0%)    1/27 (4%)    2/27 (7%)    0/0 (0%)    |                                                    | 
|FIRST INCIDENCE    |     676          729 (T)      729 (T)      ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.860      P=0.726N     P=0.541      P=0.970N    |                                                    | 
|POLY 3             |     P=0.471N     P=0.741N     P=0.528      P=0.582N    |                                                    | 
|POLY 1.5           |     P=0.394N     P=0.744N     P=0.525      P=0.537N    |                                                    | 
|POLY 6             |     P=0.588N     P=0.736N     P=0.530      P=0.651N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.811N     P=0.741N     P=0.535      P=0.722N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.312N     P=0.742N     P=0.515      P=0.490N    |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    1/49 (2%)    3/50 (6%)    0/50 (0%)   |0/49 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/38.94      1/41.82      3/42.48      0/25.17     |0/42.42      1/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         7.1%         0.0%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    1/27 (4%)    0/0 (0%)    |0/30 (0%)    1/31 (3%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          614          627          ---         |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.664      P=0.510      P=0.148      (e)         |P=0.612N     P=0.507      (e)          (e)          | 
|POLY 3             |     P=0.646N     P=0.514      P=0.134      (e)         |P=0.611N     P=0.503      (e)          (e)          | 
|POLY 1.5           |     P=0.539N     P=0.509      P=0.130      (e)         |P=0.608N     P=0.504      (e)          (e)          | 
|POLY 6             |     P=0.388      P=0.522      P=0.139      (e)         |P=0.615N     P=0.501      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.552N     P=0.470      P=0.132      (e)         |(e)          P=0.507      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.431N     P=0.500      P=0.125      (e)         |P=0.607N     P=0.505      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    2/49 (4%)    0/50 (0%)    0/50 (0%)   |0/49 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/38.94      2/42.56      0/42.10      0/25.17     |0/42.42      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          505          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.452N     P=0.250      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.416N     P=0.257      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.407N     P=0.250      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.387N     P=0.268      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.285N     P=0.146      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.386N     P=0.247      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    5/50 (10%)   4/50 (8%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/39.90      5/42.97      4/42.36      0/25.17     |0/43.16      1/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     2.5%         11.6%        9.4%         0.0%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    4/27 (15%)   2/27 (7%)    0/0 (0%)    |0/30 (0%)    1/31 (3%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      554          674          ---         |---          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.759      P=0.134      P=0.231      P=1.000N    |P=0.612N     P=0.507      (e)          (e)          | 
|POLY 3             |     P=0.262N     P=0.118      P=0.196      P=0.588N    |P=0.612N     P=0.499      (e)          (e)          | 
|POLY 1.5           |     P=0.167N     P=0.112      P=0.191      P=0.544N    |P=0.610N     P=0.500      (e)          (e)          | 
|POLY 6             |     P=0.453N     P=0.128      P=0.203      P=0.654N    |P=0.616N     P=0.498      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.395N     P=0.117      P=0.205      (e)         |(e)          P=0.507      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.097N     P=0.102      P=0.181      P=0.500N    |P=0.608N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   5/50 (10%)   3/50 (6%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     6/40.71      5/42.95      3/42.15      1/25.33     |1/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     14.7%        11.6%        7.1%         4.0%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/23 (13%)   4/27 (15%)   2/27 (7%)    0/0 (0%)    |1/30 (3%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     569          564          718          690         |729 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.680      P=0.409N     P=0.180N     P=0.481     |P=0.550N     P=0.493N     P=0.453N     P=0.493N     | 
|POLY 3             |     P=0.143N     P=0.462N     P=0.223N     P=0.175N    |P=0.551N     P=0.501N     P=0.488N     P=0.498N     | 
|POLY 1.5           |     P=0.091N     P=0.475N     P=0.228N     P=0.102N    |P=0.550N     P=0.500N     P=0.492N     P=0.497N     | 
|POLY 6             |     P=0.218N     P=0.444N     P=0.220N     P=0.361N    |P=0.553N     P=0.502N     P=0.483N     P=0.500N     | 
|LOGISTIC REGRESSION|     P=0.242N     P=0.467N     P=0.212N     P=0.450N    |P=0.550N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047N*    P=0.500N     P=0.243N     P=0.056N    |P=0.547N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   5/50 (10%)   7/50 (14%)   1/50 (2%)   |1/50 (2%)    2/50 (4%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     9/41.54      5/42.95      7/42.15      1/25.33     |1/43.16      2/43.21      2/46.12      0/43.66      | 
|POLY-3 PERCENT (g) |     21.7%        11.6%        16.6%        4.0%        |2.3%         4.6%         4.3%         0.0%         | 
|TERMINAL (d)       |     3/23 (13%)   4/27 (15%)   6/27 (22%)   0/0 (0%)    |1/30 (3%)    1/31 (3%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     511          564          718          690         |729 (T)      683          665          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.627      P=0.138N     P=0.283N     P=0.717     |P=0.237N     P=0.498      P=0.566      P=0.493N     | 
|POLY 3             |     P=0.107N     P=0.171N     P=0.378N     P=0.058N    |P=0.232N     P=0.500      P=0.523      P=0.498N     | 
|POLY 1.5           |     P=0.047N*    P=0.177N     P=0.378N     P=0.023N*   |P=0.231N     P=0.501      P=0.514      P=0.497N     | 
|POLY 6             |     P=0.258N     P=0.161N     P=0.385N     P=0.205N    |P=0.237N     P=0.500      P=0.534      P=0.500N     | 
|LOGISTIC REGRESSION|     P=0.136N     P=0.180N     P=0.348N     P=0.068N    |P=0.231N     P=0.498      P=0.516      (e)          | 
|COCH-ARM / FISHERS |     P=0.016N*    P=0.194N     P=0.393N     P=0.008N**  |P=0.233N     P=0.500      P=0.500      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    4/50 (8%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/39.90      3/42.97      4/42.36      0/25.17     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     2.5%         7.0%         9.4%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    2/27 (7%)    2/27 (7%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      554          674          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.704      P=0.347      P=0.231      P=1.000     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.378N     P=0.332      P=0.196      P=0.588N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.264N     P=0.322      P=0.191      P=0.544N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.578      P=0.347      P=0.203      P=0.654N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.448N     P=0.315      P=0.205      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.168N     P=0.309      P=0.181      P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    5/50 (10%)   0/50 (0%)   |0/50 (0%)    2/50 (4%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/40.73      0/42.41      5/42.15      0/25.17     |0/43.16      2/43.21      2/46.12      0/43.66      | 
|POLY-3 PERCENT (g) |     7.4%         0.0%         11.9%        0.0%        |0.0%         4.6%         4.3%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    4/27 (15%)   0/0 (0%)    |0/30 (0%)    1/31 (3%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     511          ---          718          ---         |---          683          665          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.658      P=0.101N     P=0.444      P=0.537N    |P=0.352N     P=0.234      P=0.277      (e)          | 
|POLY 3             |     P=0.425N     P=0.111N     P=0.374      P=0.228N    |P=0.343N     P=0.237      P=0.252      (e)          | 
|POLY 1.5           |     P=0.293N     P=0.114N     P=0.371      P=0.166N    |P=0.342N     P=0.238      P=0.246      (e)          | 
|POLY 6             |     P=0.504      P=0.107N     P=0.377      P=0.357N    |P=0.348N     P=0.237      P=0.259      (e)          | 
|LOGISTIC REGRESSION|     P=0.433N     P=0.130N     P=0.382      P=0.127N    |P=0.344N     P=0.237      P=0.239      (e)          | 
|COCH-ARM / FISHERS |     P=0.183N     P=0.121N     P=0.357      P=0.121N    |P=0.346N     P=0.247      P=0.247      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/39.90      2/42.41      0/42.10      0/25.17     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    2/27 (7%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.970N     P=0.274      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.423N     P=0.251      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.413N     P=0.246      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.395N     P=0.258      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.274      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.390N     P=0.247      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    5/50 (10%)   4/50 (8%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/39.90      5/42.97      4/42.36      0/25.17     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     2.5%         11.6%        9.4%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    4/27 (15%)   2/27 (7%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      554          674          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.759      P=0.134      P=0.231      P=1.000N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.262N     P=0.118      P=0.196      P=0.588N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.167N     P=0.112      P=0.191      P=0.544N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.453N     P=0.128      P=0.203      P=0.654N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.395N     P=0.117      P=0.205      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.097N     P=0.102      P=0.181      P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/39.90      0/42.41      0/42.10      0/25.17     |2/44.12      1/43.04      0/45.88      1/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.5%         2.3%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |1/30 (3%)    1/31 (3%)    0/38 (0%)    1/31 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |247          729 (T)      ---          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.566N     P=0.492N     P=0.214N     P=0.492N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.566N     P=0.509N     P=0.229N     P=0.504N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.563N     P=0.506N     P=0.233N     P=0.501N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.570N     P=0.511N     P=0.223N     P=0.508N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.631N     P=0.549N     P=0.308N     P=0.647N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.563N     P=0.500N     P=0.247N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/39.90      0/42.41      0/42.10      0/25.17     |2/44.12      1/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |4.5%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |1/30 (3%)    1/31 (3%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |247          729 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.211N     P=0.492N     P=0.214N     P=0.236N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.214N     P=0.509N     P=0.229N     P=0.239N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.213N     P=0.506N     P=0.233N     P=0.238N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.217N     P=0.511N     P=0.223N     P=0.242N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.266N     P=0.549N     P=0.308N     P=0.414N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.212N     P=0.500N     P=0.247N     P=0.247N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/50 (90%)  45/50 (90%)  43/50 (86%)  48/50 (96%) |                                                    | 
|POLY-3 RATE (b)    |     45/46.66     45/47.76     43/46.59     48/48.38    |                                                    | 
|POLY-3 PERCENT (g) |     96.5%        94.2%        92.3%        99.2%       |                                                    | 
|TERMINAL (d)       |     23/23 (100%) 25/27 (93%)  27/27 (100%) 0/0 (0%)    |                                                    | 
|FIRST INCIDENCE    |     511          528          562          398         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.221N     P=0.151N     P<0.001 **  |                                                    | 
|POLY 3             |     P=0.145      P=0.488N     P=0.297N     P=0.385     |                                                    | 
|POLY 1.5           |     P=0.140      P=0.517N     P=0.278N     P=0.310     |                                                    | 
|POLY 6             |     P=0.168      P=0.474N     P=0.477N     P=0.496     |                                                    | 
|LOGISTIC REGRESSION|     P=0.002 **   P=0.429N     P=0.101N     P=0.038 *   |                                                    | 
|COCH-ARM / FISHERS |     P=0.139      P=0.630N     P=0.380N     P=0.218     |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/42 (10%)   4/47 (9%)    6/48 (13%)   0/47 (0%)   |6/45 (13%)   8/45 (18%)   3/46 (7%)    3/46 (7%)    | 
|POLY-3 RATE (b)    |     4/36.69      4/40.42      6/42.61      0/23.82     |6/39.85      8/39.85      3/44.27      3/41.30      | 
|POLY-3 PERCENT (g) |     10.9%        9.9%         14.1%        0.0%        |15.1%        20.1%        6.8%         7.3%         | 
|TERMINAL (d)       |     1/23 (4%)    2/27 (7%)    3/27 (11%)   0/0 (0%)    |5/30 (17%)   6/31 (19%)   2/38 (5%)    1/31 (3%)    | 
|FIRST INCIDENCE    |     568          649          562          ---         |626          721          598          681          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.544N     P=0.570N     P=0.422      P=0.461N    |P=0.129N     P=0.411      P=0.157N     P=0.237N     | 
|POLY 3             |     P=0.175N     P=0.590N     P=0.466      P=0.138N    |P=0.117N     P=0.385      P=0.192N     P=0.223N     | 
|POLY 1.5           |     P=0.090N     P=0.587N     P=0.463      P=0.083N    |P=0.115N     P=0.389      P=0.204N     P=0.222N     | 
|POLY 6             |     P=0.376N     P=0.589N     P=0.467      P=0.275N    |P=0.122N     P=0.377      P=0.180N     P=0.228N     | 
|LOGISTIC REGRESSION|     P=0.043N*    P=0.581N     P=0.427      P=0.054N    |P=0.115N     P=0.387      P=0.222N     P=0.223N     | 
|COCH-ARM / FISHERS |     P=0.036N*    P=0.578N     P=0.458      P=0.046N*   |P=0.117N     P=0.386      P=0.231N     P=0.231N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/42 (5%)    3/47 (6%)    2/48 (4%)    0/47 (0%)   |1/45 (2%)    1/45 (2%)    2/46 (4%)    1/46 (2%)    | 
|POLY-3 RATE (b)    |     2/36.20      3/40.10      2/41.39      0/23.82     |1/39.48      1/39.80      2/43.82      1/41.10      | 
|POLY-3 PERCENT (g) |     5.5%         7.5%         4.8%         0.0%        |2.5%         2.5%         4.6%         2.4%         | 
|TERMINAL (d)       |     1/23 (4%)    2/27 (7%)    1/27 (4%)    0/0 (0%)    |1/30 (3%)    1/31 (3%)    2/38 (5%)    1/31 (3%)    | 
|FIRST INCIDENCE    |     569          717          726          ---         |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.617N     P=0.566      P=0.637N     P=0.574N    |P=0.639N     P=0.755N     P=0.583      P=0.755N     | 
|POLY 3             |     P=0.222N     P=0.547      P=0.646N     P=0.341N    |P=0.622N     P=0.759N     P=0.536      P=0.752N     | 
|POLY 1.5           |     P=0.164N     P=0.548      P=0.644N     P=0.274N    |P=0.620N     P=0.759N     P=0.527      P=0.752N     | 
|POLY 6             |     P=0.307N     P=0.551      P=0.649N     P=0.460N    |P=0.626N     P=0.760N     P=0.546      P=0.754N     | 
|LOGISTIC REGRESSION|     P=0.295N     P=0.552      P=0.646N     P=0.233N    |P=0.639N     P=0.755N     P=0.583      P=0.755N     | 
|COCH-ARM / FISHERS |     P=0.106N     P=0.554      P=0.640N     P=0.220N    |P=0.625N     P=0.753N     P=0.508      P=0.747N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/42 (14%)   7/47 (15%)   8/48 (17%)   0/47 (0%)   |7/45 (16%)   9/45 (20%)   5/46 (11%)   4/46 (9%)    | 
|POLY-3 RATE (b)    |     6/37.21      7/40.47      8/42.62      0/23.82     |7/39.85      9/39.85      5/44.27      4/41.30      | 
|POLY-3 PERCENT (g) |     16.1%        17.3%        18.8%        0.0%        |17.6%        22.6%        11.3%        9.7%         | 
|TERMINAL (d)       |     2/23 (9%)    4/27 (15%)   4/27 (15%)   0/0 (0%)    |6/30 (20%)   7/31 (23%)   4/38 (11%)   2/31 (7%)    | 
|FIRST INCIDENCE    |     568          649          562          ---         |626          721          598          681          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.426N     P=0.598      P=0.466      P=0.277N    |P=0.143N     P=0.419      P=0.244N     P=0.252N     | 
|POLY 3             |     P=0.077N     P=0.566      P=0.494      P=0.059N    |P=0.128N     P=0.390      P=0.307N     P=0.238N     | 
|POLY 1.5           |     P=0.027N*    P=0.573      P=0.496      P=0.026N*   |P=0.126N     P=0.395      P=0.325N     P=0.238N     | 
|POLY 6             |     P=0.246N     P=0.563      P=0.489      P=0.176N    |P=0.133N     P=0.382      P=0.289N     P=0.244N     | 
|LOGISTIC REGRESSION|     P=0.017N*    P=0.587      P=0.471      P=0.010N*   |P=0.127N     P=0.392      P=0.330N     P=0.240N     | 
|COCH-ARM / FISHERS |     P=0.007N**   P=0.588      P=0.494      P=0.009N**  |P=0.129N     P=0.392      P=0.363N     P=0.248N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |8/50 (16%)   12/50 (24%)  6/50 (12%)   12/50 (24%)  | 
|POLY-3 RATE (b)    |                                                        |8/43.19      12/44.68     6/46.50      12/45.31     | 
|POLY-3 PERCENT (g) |                                                        |18.5%        26.9%        12.9%        26.5%        | 
|TERMINAL (d)       |                                                        |6/30 (20%)   7/31 (23%)   4/38 (11%)   7/31 (23%)   | 
|FIRST INCIDENCE    |                                                        |724          585          600          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.258      P=0.256      P=0.245N     P=0.259      | 
|POLY 3             |                                                        |P=0.281      P=0.249      P=0.330N     P=0.260      | 
|POLY 1.5           |                                                        |P=0.279      P=0.240      P=0.352N     P=0.251      | 
|POLY 6             |                                                        |P=0.277      P=0.263      P=0.303N     P=0.267      | 
|LOGISTIC REGRESSION|                                                        |P=0.267      P=0.223      P=0.327N     P=0.234      | 
|COCH-ARM / FISHERS |                                                        |P=0.262      P=0.227      P=0.387N     P=0.227      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 21      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |                                                        |1/43.16      0/43.04      2/46.31      0/43.66      | 
|POLY-3 PERCENT (g) |                                                        |2.3%         0.0%         4.3%         0.0%         | 
|TERMINAL (d)       |                                                        |1/30 (3%)    0/31 (0%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |                                                        |729 (T)      ---          604          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.441N     P=0.493N     P=0.562      P=0.493N     | 
|POLY 3             |                                                        |P=0.432N     P=0.501N     P=0.524      P=0.498N     | 
|POLY 1.5           |                                                        |P=0.432N     P=0.500N     P=0.515      P=0.497N     | 
|POLY 6             |                                                        |P=0.435N     P=0.502N     P=0.536      P=0.500N     | 
|LOGISTIC REGRESSION|                                                        |P=0.437N     (e)          P=0.495      (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.437N     P=0.500N     P=0.500      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |9/50 (18%)   12/50 (24%)  8/50 (16%)   12/50 (24%)  | 
|POLY-3 RATE (b)    |                                                        |9/43.19      12/44.68     8/46.93      12/45.31     | 
|POLY-3 PERCENT (g) |                                                        |20.8%        26.9%        17.1%        26.5%        | 
|TERMINAL (d)       |                                                        |7/30 (23%)   7/31 (23%)   5/38 (13%)   7/31 (23%)   | 
|FIRST INCIDENCE    |                                                        |724          585          600          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.336      P=0.342      P=0.328N     P=0.346      | 
|POLY 3             |                                                        |P=0.367      P=0.340      P=0.425N     P=0.354      | 
|POLY 1.5           |                                                        |P=0.364      P=0.330      P=0.455N     P=0.342      | 
|POLY 6             |                                                        |P=0.362      P=0.358      P=0.388N     P=0.363      | 
|LOGISTIC REGRESSION|                                                        |P=0.348      P=0.307      P=0.448N     P=0.320      | 
|COCH-ARM / FISHERS |                                                        |P=0.343      P=0.312      P=0.500N     P=0.312      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 22      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/41.42      2/43.08      1/42.17      1/25.96     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     7.2%         4.6%         2.4%         3.9%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     376          558          712          438         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.601N     P=0.460N     P=0.272N     P=0.533N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.423N     P=0.482N     P=0.298N     P=0.484N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.371N     P=0.489N     P=0.300N     P=0.392N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.456N     P=0.470N     P=0.297N     P=0.632N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.147N     P=0.615N     P=0.383N     P=0.180N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.299N     P=0.500N     P=0.309N     P=0.309N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/39.90      1/42.42      0/42.10      0/25.17     |0/43.16      0/43.04      0/45.88      2/44.11      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.5%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    1/31 (3%)    | 
|FIRST INCIDENCE    |     ---          726          ---          ---         |---          ---          ---          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.999N     P=0.546      (e)          (e)         |P=0.040 *    (e)          (e)          P=0.246      | 
|POLY 3             |     P=0.605N     P=0.512      (e)          (e)         |P=0.042 *    (e)          (e)          P=0.242      | 
|POLY 1.5           |     P=0.614N     P=0.508      (e)          (e)         |P=0.042 *    (e)          (e)          P=0.242      | 
|POLY 6             |     P=0.541N     P=0.519      (e)          (e)         |P=0.042 *    (e)          (e)          P=0.241      | 
|LOGISTIC REGRESSION|     P=0.995N     P=0.543      (e)          (e)         |P=0.038 *    (e)          (e)          P=0.224      | 
|COCH-ARM / FISHERS |     P=0.608N     P=0.500      (e)          (e)         |P=0.042 *    (e)          (e)          P=0.247      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 23      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/39.90      0/42.41      0/42.10      0/25.17     |0/43.16      0/43.04      2/46.32      0/43.66      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.3%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/27 (0%)    0/27 (0%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    1/38 (3%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          600          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.659N     (e)          P=0.276      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.646N     (e)          P=0.253      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.647N     (e)          P=0.247      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.649N     (e)          P=0.261      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.662N     (e)          P=0.220      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.652N     (e)          P=0.247      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     16/50 (32%)  20/50 (40%)  22/50 (44%)  5/50 (10%)  |10/50 (20%)  10/50 (20%)  4/50 (8%)    13/50 (26%)  | 
|POLY-3 RATE (b)    |     16/42.81     20/44.92     22/44.59     5/27.46     |10/44.54     10/46.53     4/47.17      13/46.05     | 
|POLY-3 PERCENT (g) |     37.4%        44.5%        49.3%        18.2%       |22.5%        21.5%        8.5%         28.2%        | 
|TERMINAL (d)       |     6/23 (26%)   8/27 (30%)   12/27 (44%)  0/0 (0%)    |5/30 (17%)   4/31 (13%)   2/38 (5%)    4/31 (13%)   | 
|FIRST INCIDENCE    |     564          550          584          408         |543          417          295          597          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.043 *    P=0.467      P=0.307      P=0.154     |P=0.175      P=0.577N     P=0.046N*    P=0.335      | 
|POLY 3             |     P=0.055N     P=0.320      P=0.176      P=0.075N    |P=0.166      P=0.556N     P=0.056N     P=0.348      | 
|POLY 1.5           |     P=0.007N**   P=0.301      P=0.171      P=0.022N*   |P=0.167      P=0.568N     P=0.061N     P=0.341      | 
|POLY 6             |     P=0.384N     P=0.354      P=0.179      P=0.320N    |P=0.166      P=0.548N     P=0.052N     P=0.356      | 
|LOGISTIC REGRESSION|     P=0.022N*    P=0.305      P=0.184      P=0.042N*   |P=0.131      P=0.590      P=0.095N     P=0.310      | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.266      P=0.151      P=0.006N**  |P=0.168      P=0.598N     P=0.074N     P=0.318      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 24      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   2/50 (4%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     6/41.07      2/43.51      2/42.10      2/25.99     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     14.6%        4.6%         4.8%         7.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    0/27 (0%)    2/27 (7%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     569          554          729 (T)      610         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.432      P=0.120N     P=0.111N     P=0.396     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.412N     P=0.113N     P=0.123N     P=0.328N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.338N     P=0.120N     P=0.125N     P=0.217N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.473N     P=0.105N     P=0.123N     P=0.546N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.241N     P=0.151N     P=0.123N     P=0.315N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.134N     P=0.134N     P=0.134N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/50 (12%)   2/50 (4%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     6/41.07      2/43.51      2/42.10      2/25.99     |0/43.16      0/43.04      0/45.88      0/43.66      | 
|POLY-3 PERCENT (g) |     14.6%        4.6%         4.8%         7.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    0/27 (0%)    2/27 (7%)    0/0 (0%)    |0/30 (0%)    0/31 (0%)    0/38 (0%)    0/31 (0%)    | 
|FIRST INCIDENCE    |     569          554          729 (T)      610         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.432      P=0.120N     P=0.111N     P=0.396     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.412N     P=0.113N     P=0.123N     P=0.328N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.338N     P=0.120N     P=0.125N     P=0.217N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.473N     P=0.105N     P=0.123N     P=0.546N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.241N     P=0.151N     P=0.123N     P=0.315N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.134N     P=0.134N     P=0.134N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 25      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     47/50 (94%)  49/50 (98%)  50/50 (100%) 49/50 (98%) |44/50 (88%)  45/50 (90%)  40/50 (80%)  36/50 (72%)  | 
|POLY-3 RATE (b)    |     47/47.27     49/49.25     50/50.00     49/49.18    |44/47.54     45/47.12     40/47.71     36/46.69     | 
|POLY-3 PERCENT (g) |     99.4%        99.5%        100.0%       99.6%       |92.6%        95.5%        83.8%        77.1%        | 
|TERMINAL (d)       |     23/23 (100%) 27/27 (100%) 27/27 (100%) 0/0 (0%)    |30/30 (100%) 30/31 (97%)  33/38 (87%)  25/31 (81%)  | 
|FIRST INCIDENCE    |     511          417          340          398         |247          542          597          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.306N     P=0.405N     P<0.001 **  |P=0.061N     P=0.562      P=0.012N*    P=0.080N     | 
|POLY 3             |     P=0.993      P=0.999      P=1.000      P=1.000     |P=0.003N**   P=0.417      P=0.137N     P=0.021N*    | 
|POLY 1.5           |     P=0.763      P=0.792      P=0.577      P=0.778     |P=0.004N**   P=0.425      P=0.174N     P=0.027N*    | 
|POLY 6             |     P=1.000      P=1.000N     P=1.000      P=1.000N    |P=0.003N**   P=0.507      P=0.095N     P=0.019N*    | 
|LOGISTIC REGRESSION|     P=0.376      P=0.895      P=0.274      P=0.980     |P=0.004N**   P=0.516      P=0.104N     P=0.022N*    | 
|COCH-ARM / FISHERS |     P=0.409      P=0.309      P=0.121      P=0.309     |P=0.010N*    P=0.500      P=0.207N     P=0.039N*    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     35/50 (70%)  34/50 (68%)  35/50 (70%)  13/50 (26%) |25/50 (50%)  24/50 (48%)  20/50 (40%)  21/50 (42%)  | 
|POLY-3 RATE (b)    |     35/48.06     34/49.10     35/47.55     13/31.09    |25/46.20     24/47.47     20/49.30     21/47.92     | 
|POLY-3 PERCENT (g) |     72.8%        69.2%        73.6%        41.8%       |54.1%        50.6%        40.6%        43.8%        | 
|TERMINAL (d)       |     12/23 (52%)  14/27 (52%)  18/27 (67%)  0/0 (0%)    |15/30 (50%)  13/31 (42%)  12/38 (32%)  8/31 (26%)   | 
|FIRST INCIDENCE    |     323          456          340          408         |540          417          295          533          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.028 *    P=0.287N     P=0.344N     P=0.044 *   |P=0.326N     P=0.468N     P=0.085N     P=0.294N     | 
|POLY 3             |     P=0.004N**   P=0.434N     P=0.559      P=0.003N**  |P=0.245N     P=0.445N     P=0.130N     P=0.212N     | 
|POLY 1.5           |     P<0.001N**   P=0.455N     P=0.587      P<0.001N**  |P=0.253N     P=0.458N     P=0.154N     P=0.229N     | 
|POLY 6             |     P=0.193N     P=0.405N     P=0.505      P=0.127N    |P=0.237N     P=0.436N     P=0.107N     P=0.197N     | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.565N     P=0.561      P<0.001N**  |P=0.295N     P=0.501N     P=0.244N     P=0.284N     | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.500N     P=0.586N     P<0.001N**  |P=0.277N     P=0.500N     P=0.211N     P=0.274N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/04/02                           EXPERIMENT: 88031 TEST: 05                                            Page 26      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                 DIPROPYLENE GLYCOL         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0.0%         0.25%        1.0%         4.0%        |0.0%         0.25%        1.0%         4.0%         | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  50/50 (100%) 50/50 (100%) 50/50 (100%)|50/50 (100%) 49/50 (98%)  46/50 (92%)  46/50 (92%)  | 
|POLY-3 RATE (b)    |     49/49.05     50/50.00     50/50.00     50/50.00    |50/50.00     49/49.20     46/50.00     46/49.51     | 
|POLY-3 PERCENT (g) |     99.9%        100.0%       100.0%       100.0%      |100.0%       99.6%        92.0%        92.9%        | 
|TERMINAL (d)       |     23/23 (100%) 27/27 (100%) 27/27 (100%) 0/0 (0%)    |30/30 (100%) 31/31 (100%) 34/38 (90%)  28/31 (90%)  | 
|FIRST INCIDENCE    |     323          417          340          398         |247          417          295          533          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.261N     P=0.299N     P<0.001 **  |P=0.342N     P=0.443N     P=0.022N*    P=0.274N     | 
|POLY 3             |     P=1.000      P=1.000      P=1.000      P=1.000     |P=0.061N     P=1.000N     P=0.061N     P=0.075N     | 
|POLY 1.5           |     P=1.000      P=1.000      P=1.000      P=1.000     |P=0.058N     P=0.891N     P=0.061N     P=0.067N     | 
|POLY 6             |     P=1.000      P=1.000      P=1.000      P=1.000     |P=0.073N     P=1.000N     P=0.061N     P=0.091N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.066N     P=0.363N     (e)          P=0.063N     | 
|COCH-ARM / FISHERS |     P=0.547      P=0.500      P=0.500      P=0.500     |P=0.069N     P=0.500N     P=0.059N     P=0.059N     | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).